Transducer Probe Cover

FDA 510(k) K241615 · Hony Medical Co., Ltd.

Substantially Equivalent

510(k) numberK241615

Submission

Device name
Transducer Probe Cover
Applicant
Hony Medical Co., Ltd.
Taishan, CN
Received
June 5, 2024
Decision date
July 3, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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More from Vitrolife Sweden AB

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K241789Non-Sterile Ultrasound Transmission GelsMUI · Traditional 07/24/2024SE
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K221999Ultrasound Transmission GelsMUI · Traditional 08/30/2022SE

Questions and answers

When was Transducer Probe Cover cleared by the FDA?

Transducer Probe Cover (K241615) received a 510(k) decision of Substantially Equivalent on July 3, 2024, 28 days after the submission was received.

What is the product code of K241615?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.